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KEYU Urine Sediment Analyzer Quality Control

by Zhuhai Keyu Biological Engineering Co., Ltd China EUDAMED

Ref KU-UQC-02 EMDN W0101050102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974735360484 Basic UDI-DIDate13 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Urine Sediment Analyzer Quality Control
Model / Reference
KU-UQC-02
Primary DI / UDI-DI
06974735360484
Basic UDI-DI
B-06974735360484
EMDN Code
W0101050102 Unassayed multicomponent controls (cc)
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000023195
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zhuhai Keyu Biological Engineering Co., Ltd

See all devices from Zhuhai Keyu Biological Engineering Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED bd2633fd-469c-4e9c-bd31-453fb63263b2 61 fields · synced 25 Oct 2026